Clinical relevance of bioequivalence acceptance criteria. The example of terbinafine

Arzneimittel-Forschung
Rossen KoytchevSerdar Alpan

Abstract

The present study was conducted with the aim of investigating which acceptance criteria for bioequivalence are relevant for orally applied antimycotics using terbinafine (CAS 78628-80-5) as an example. A bioequivalence trial was performed in 18 healthy male volunteers with the aim of comparing a new generic product (tablets containing terbinafine hydrochloride, equivalent to 250 mg base) with the originator product. The trial was performed according to an open, cross-over design in one study centre. In each of the two study periods (separated by a wash-out of 14 days) a single dose of one 250 mg tablet (test or reference) was administered. Blood samples were taken up to 72 h post dose, the plasma was separated and the concentrations of terbinafine were determined by a liquid chromatography-mass spectrometry (LC-MS-MS) method with a quantification limit of 14 ng/ml. AUC0-infinity, AUC0-tlast, Cmax and tmax were calculated for both formulations and compared according to the currently valid CPMP Note for Guidance for the evaluation of Bioavailability and Bioequivalence. The parametric 90% confidence intervals for the primary target parameters were between 0.89 and 1.09 AUC0-tlast and between 0.71 and 0.95 for Cmax. The acceptance ...Continue Reading

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